The New Drugs and Clinical Trials (Amendment) Rules, 2026 streamline India’s test license framework. Key changes include replacing “permission” with “permission or prior intimation”, allowing certain drug categories to be manufactured upon acknowledgment of online intimation. Approval timelines are reduced from ninety to forty‑five working days. Manufacturers must follow Good Manufacturing Practices, maintain records, and restrict use to trials or analysis. Non‑compliance may lead to suspension or cancellation, with appeal rights to the Central Government.
The Ministry of Health and Family Welfare issued the New Drugs and Clinical Trials (Amendment) Rules, 2026, revising provisions under the NDCT Rules, 2019 regarding test licenses. The amendments introduce a dual mechanism of “permission or prior intimation” for manufacturing new drugs or investigational new drugs for clinical trials, bioavailability/bioequivalence studies, or analytical testing.
Applicants must submit Form CT‑10 online, but for certain categories-excluding hormones, cytotoxics, beta‑lactams, biologics with live microorganisms, narcotics, and psychotropics-manufacture can proceed on the basis of acknowledgment of prior intimation.
Timelines for regulatory decisions are shortened from ninety to forty‑five working days across Rules 53, 60, and related provisions. Rules 54–57 expand conditions to cover both permissions and acknowledgments, requiring manufacturers to limit use strictly to trials or analysis, follow Good Manufacturing Practices, and maintain detailed records. Suspension or cancellation of permissions or acknowledgments is allowed for non‑compliance, with appeal rights to the Central Government.
Further, Rules 59–63 extend the prior intimation mechanism to pharmaceutical formulations and active pharmaceutical ingredients via Forms CT‑12 to CT‑15. These provisions emphasize stricter oversight, faster approvals, and clear compliance obligations, ensuring transparency and accountability in India’s clinical trial and test license framework.